Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
- Conditions
- Leukemia
- Registration Number
- NCT00274976
- Lead Sponsor
- German CLL Study Group
- Brief Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.
- Detailed Description
OBJECTIVES:
* Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.
* Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain \[IgVH\] status, del \[17p\], del \[11q\]) treated with subcutaneous alemtuzumab after progression on fludarabine.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy Response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
Haematolo-Onkologische Schwerpunktpraxis - Berlin
🇩🇪Berlin, Germany
Specialist Practice for Oncology
🇩🇪Aschaffenburg, Germany
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Vienna, Austria
Internistische Gemeinschaftspraxis - Kassel
🇩🇪Kassel, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
🇩🇪Berlin, Germany
Hospital Kuchwald Chemnitz
🇩🇪Chemnitz, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Staedtische Kliniken Esslingen
🇩🇪Esslingen, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Internistische Gemeinschaftspraxis - Halle
🇩🇪Halle, Germany
Praxis fur Innere Medizin - Hamburg
🇩🇪Hamburg, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitaets-Kinderklinik Heidelberg
🇩🇪Heidelberg, Germany
Marienhospital at Ruhr University Bochum
🇩🇪Herne, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Internistische Praxis - Landshut
🇩🇪Landshut, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany